Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Phase 3

Completed

• Conditions: Involutional Osteoporosis

• Registration Number: NCT00212667
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Primary Completion: 2006-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 650

Inclusion Criteria

1. Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
2. Patients having radiographically confirmed vertebral (T4-L4) fractures
3. Other inclusion criteria as specified in the study protocol

Exclusion Criteria

1. Patients having secondary osteoporosis or another condition that presents low bone mass
2. Patients having findings on X-ray that affect evaluation of vertebral fracture
3. Patients that have been administered bisphosphonate derivatives
4. Other exclusion criteria as specified in the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
New fragility vertebral fracture

Secondary Outcome Measures

Name	Time	Method
New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain